Study of Morphology and Functional Magnetic Resonance Imaging (MRI) Muscle Patients With Muscular Dystrophy Type FSHD Benefiting a Physical Training Introduced. (FSHD3)

July 27, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

The safety of guided practice of physical activity in myopathies is increasingly accepted, including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most common muscular dystrophy, the aerobic training showed its physiological and functional efficiency without affecting the quality of life of patients. The issue of exercise therapy extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use of a training program combining endurance exercise targeted exercises and strength is even more relevant.

To complete the multidimensional assessments be managed by each team ( physiological assessments, functional tissue and quality of life) it is relevant to continue , for a descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

These non-invasive assessments already in place at the time of the initial training (FSHD1 study, NCT01116570) will be repeated in the medium (12 months) and long term (30 months) in the same laboratory NMR AIM - CEA , Institute of Myology in Paris (P Carlier ). The data obtained from NMR repeated examinations and those obtained from biochemical analyzes and additional muscle histomorphometric (cellular aging estimation of involution fibroadipose ) on biopsies already programmed (initial, 6 months and 30 months, FSHD2 study, NCT01689480) will be respectively compared to initial time to follow the evolution food and energy capacity of trained muscles. The study of biopsies provide mechanistic arguments and morphometric specific cellular response to exercise, data will be advantageously complemented by NMR specialized examinations extended to all the muscles of the thigh (target of training ) and muscle quantification whole body MRI.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CHU de Grenbole
      • St Etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 and FSHD2 studies

Description

Inclusion Criteria:

  • Included in the FSHD1 and FSHD2 studies
  • Social Security regimen affiliated
  • Consent form signed

Exclusion Criteria:

  • Severe cardiac or respiratory insufficiency
  • Cardiac pacemaker
  • Morbid obesity (BMI upper to 35)
  • Anti platelet therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FSHD training
Only the patients who have participated to the FSHD1 study (NCT01116570) and the FSHD2 study (NCT01689480) can be included in this study.
Device: MRI
In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.
Procedure: Biopsy
biopsy of the vastus lateralis muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters of MRI
Time Frame: 30 months
whole body imaging T1, T2-weighted
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle tissue parameters
Time Frame: 30 months
muscle biopsy
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France
Association Française contre les Myopathies (AFM), Paris

Investigators

  • Principal Investigator: Léonard FEASSON, MD-PhD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208050
  • 2012-A00430-43 (Other Identifier: AFFSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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